Needleless connector with compressible valve

ABSTRACT

Needleless connectors are described. An example needleless connector includes a housing and a compressible valve. The housing may define an internal cavity and may include a body section having a first port and one or more internal contact tabs and a base section having a valve mount and a second port. The compressible valve may be disposed within at least a portion of the internal cavity and be movably retained within the housing. The compressible valve may include a flange portion for securing the compressible valve within the housing. A central longitudinal axis of the housing may be defined by a coaxial arrangement of the first and second port. The one or more internal contact tabs may be arranged to contact an outer side surface of the flange portion such that a radial force substantially orthogonal to the central longitudinal axis is provided for securement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/868,180, entitled “NEEDLELESS CONNECTOR WITH COMPRESSIBLE VALVE,”filed Sep. 28, 2015, which is a continuation of U.S. patent applicationSer. No. 14/149,753, entitled “NEEDLELESS CONNECTOR WITH COMPRESSIBLEVALVE,” filed Jan. 7, 2014, now U.S. Pat. No. 9,144,672, which is acontinuation-in-part and claims the benefit of U.S. patent applicationSer. No. 13/801,399, entitled “COLLAPSIBLE VALVE WITH INTERNAL DIMPLES,”filed on Mar. 13, 2013, now U.S. Pat. No. 9,278,205, which is acontinuation-in-part and claims the benefit of U.S. patent applicationSer. No. 13/801,412, entitled “NEEDLELESS CONNECTOR WITH FOLDING VALVE,”filed on Mar. 13, 2013, which is a continuation-in-part and claims thebenefit of U.S. patent application Ser. No. 13/829,227, entitled“NEEDLELESS CONNECTOR WITH FLEXIBLE VALVE,” filed on Mar. 14, 2013, nowU.S. Pat. No. 8,840,577, which is a continuation-in-part and claims thebenefit of U.S. patent application Ser. No. 13/829,187, entitled“NEEDLELESS CONNECTOR WITH SUPPORT MEMBER,” filed on Mar. 14, 2013, nowU.S. Pat. No. 9,089,682, and is a continuation-in-part and claims thebenefit of U.S. patent application Ser. No. 13/801,422, entitled“NEEDLELESS CONNECTOR WITH REDUCED TRAPPED VOLUME,” filed on Mar. 13,2013, now U.S. Pat. No. 9,370,651, each of which is hereby incorporatedby reference in its entirety for all purposes.

BACKGROUND

The present disclosure generally relates to needleless connectors, andmore particularly to needleless connectors with valves.

Medical treatments often include the infusion of a medical fluid, forexample a saline solution or a liquid medication, to patients using anintravenous (IV) catheter that is connected though an arrangement offlexible tubing and fittings, commonly referred to as an “IV set,” to asource of fluid, for example an IV bag. The fittings commonly includeinterconnectable male and female needleless connectors having a “Luertaper” conforming to an International Standards Organization (ISO)standard. Certain connectors have a self-sealing feature to preventleakage of fluid from the attached tubing when the connector isdecoupled from a mating connector.

SUMMARY

In accordance with certain embodiments, a needleless connector may beself-sealing and include a female Luer connector for engagement with amedical implement. The needleless connector may be reduced in sizecompared to conventional connectors and, therefore, a reduced amount offluid may be trapped, if any, within the needleless connector upondisconnection of the medical implement. The connector also accepts astandard male Luer fitting and provides a self-sealing port with acontinuous external surface at the port when the connector is notactivated such that the port may be disinfected prior to or after use.

The disclosed needleless connector overcomes many challenges discoveredwith respect to certain conventional connectors. For example, certainconventional needleless self-sealing connectors are relatively large andrequire a significant axial force on the valve element to activate theconnector. This axial force may cause stress on a fused connection ofthe housing that houses the valve element. As certain types of medicalfluids may degrade within a treatment time period, retention of medicalfluid within the connector is undesirable and may be exacerbated withlarger conventional connectors. For example, build-up of certain medicalfluids may cause occlusions that may impair the functionality of theconnector and/or hazardously release such occlusions into the IV set.

Therefore, in accordance the present disclosure, it is advantageous toprovide a disclosed needleless connector that overcomes thesechallenges. In addition, various arrangements and features of thecompressible valve and housing of the disclosed needleless connectorsare provided for improved operation and longevity of the device.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as numbered clauses or embodiments (1, 2, 3,etc.) for convenience. These are provided as examples and do not limitthe subject technology. It is noted that any of the dependent clausesmay be combined in any combination with each other or one or more otherindependent clauses, to form an independent clause. The other clausescan be presented in a similar manner. The following is a non-limitingsummary of some embodiments presented herein:

Clause 1. A needleless connector comprising: a housing defining aninternal cavity and a central longitudinal axis, the housing comprisinga body section and a base section, the body section comprising a firstport, and the base section comprising a valve mount at a top of the basesection and a second port at a bottom of the base section, the valvemount comprising an upper wall, a lower wall, and a valve mount rim,wherein the upper and lower walls extend from the valve mount rim towardthe central longitudinal axis; and a compressible valve comprising avalve wall and a flange protruding radially outward from an outersurface of the valve wall, the flange comprising an outer surface and aninner surface forming a channel, wherein, when the compressible valve iscoupled with the valve mount, the valve mount rim extends into thechannel.

Clause 2. The needleless connector of Clause 1, wherein the channelextends into the inner surface, toward the outer surface of the flange.

Clause 3. The needleless connector of Clause 1, wherein the body sectioncomprises an inner contact tab extending into the internal cavity, and,when the compressible valve is coupled with the valve mount and the bodysection, at least a portion of the flange is positioned between thevalve mount and the contact tab.

Clause 4. The needleless connector of Clause 1, wherein the valve wallcomprises a first dimple and a second dimple formed in an internalsurface.

Clause 5. The needleless connector of Clause 1, wherein base sectioncomprises a recess between the valve mount and the second port.

Clause 6. The needleless connector of Clause 5, wherein support membersextend laterally inward from the valve mount into the recess.

Clause 7. The needleless connector of Clause 5, wherein the body sectioncomprises an inner support column.

Clause 8. The needleless connector of Clause 5, wherein the valve mountrim extends from the upper wall toward the bottom of the base section.

Clause 9. A needleless connector comprising: a housing defining aninternal cavity and a central longitudinal axis, the housing comprisinga body section and a base section, the body section comprising a firstport, and the base section comprising a valve mount at a top of the basesection and a second port at a bottom of the base section, the valvemount comprising an upper wall, a lower wall, and a valve mount rim; anda compressible valve comprising a valve wall and a flange protrudingradially outward from an outer surface of the valve wall, the flangecomprising an upper lip, a lower lip, and a flange rim, wherein, whenthe compressible valve is coupled with the valve mount, the lower lipextends along the lower wall toward the central longitudinal axis.

Clause 10. The needleless connector of Clause 9, wherein the lower lipis spaced apart from the upper lip.

Clause 11. The needleless connector of Clause 9, wherein a channel isformed between an inner surface of the upper lip and an inner surface ofthe lower lip.

Clause 12. The needleless connector of Clause 9, wherein an outersurface of the flange rim tapers from the lower lip toward the upperlip.

Clause 13. The needleless connector of Clause 9, wherein a height of thelower lip taper toward the central longitudinal axis.

Clause 14. The needleless connector of Clause 9, wherein the bodysection comprises an inner contact tab extending into the internalcavity, and, when the compressible valve is coupled with the valve mountand the body section, at least a portion of the flange is positionedbetween the valve mount and the contact tab.

Clause 15. The needleless connector of Clause 9, wherein the valve wallcomprises a first dimple and a second dimple formed in an internalsurface.

Clause 16. The needleless connector of Clause 9, wherein base sectioncomprises a recess between the valve mount and the second port.

Clause 17. The needleless connector of Clause 16, wherein supportmembers extend laterally inward from the valve mount into the recess.

Clause 18. The needleless connector of Clause 17, wherein the supportmembers extend between the upper wall and a bottom surface of therecess.

Clause 19. The needleless connector of Clause 9, wherein the bodysection comprises an inner support column.

Clause 20. The needleless connector of Clause 9, wherein the valve mountrim extends from the upper wall toward the bottom of the base section.

It is understood that various configurations of the subject technologywill become readily apparent to those skilled in the art from thedisclosure, wherein various configurations of the subject technology areshown and described by way of illustration. As will be realized, thesubject technology is capable of other and different configurations andits several details are capable of modification in various otherrespects, all without departing from the scope of the subjecttechnology. Accordingly, the summary, drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1 is a perspective view illustrating an example of a needlelessconnector, in accordance with aspects of the present disclosure.

FIG. 2A is a top plan view illustrating an example of a needlelessconnector, in accordance with aspects of the present disclosure.

FIG. 2B is a front plan view illustrating an example of a needlelessconnector, in accordance with aspects of the present disclosure.

FIG. 2C is a bottom plan view illustrating an example of a needlelessconnector, in accordance with aspects of the present disclosure.

FIG. 3A is a perspective view illustrating an example of a compressiblevalve, in accordance with aspects of the present disclosure.

FIGS. 3B and 3C are front plan views illustrating an example of acompressible valve, in accordance with aspects of the presentdisclosure.

FIG. 4A is a cross-sectional view illustrating an example of acompressible valve, in accordance with aspects of the presentdisclosure.

FIG. 4B is a cross-sectional view illustrating an example of a dimpledisposed on an interior surface of a compressible valve, in accordancewith aspects of the present disclosure.

FIGS. 5A and 5B are enlarged cross-sectional views illustrating examplesections of a compressible valve, in accordance with aspects of thepresent disclosure.

FIGS. 6A and 6B are perspective views illustrating an example of a bodyportion of a housing, in accordance with aspects of the presentdisclosure.

FIG. 6C is a front plan view illustrating an example of a body portionof a housing, in accordance with aspects of the present disclosure.

FIGS. 7A and 7B are cross-sectional views illustrating an example of abody portion of a housing, in accordance with aspects of the presentdisclosure.

FIGS. 8A and 8B are perspective views illustrating an example of a baseportion of a housing, in accordance with aspects of the presentdisclosure.

FIGS. 8C and 8D are front plan views illustrating an example of a baseportion of a housing, in accordance with aspects of the presentdisclosure.

FIGS. 9A and 9B are cross-sectional views illustrating an example of abase portion of a housing, in accordance with aspects of the presentdisclosure.

FIG. 9C is a top plan view illustrating an example of a base portion ofa housing, in accordance with aspects of the present disclosure.

FIG. 10 is a cross-sectional view illustrating an example of aneedleless connector, in accordance with aspects of the presentdisclosure.

FIGS. 11A and 11B are a cross-sectional views illustrating an example ofa needleless connector in use, in accordance with aspects of the presentdisclosure.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions are provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology. Like components are labeled withidentical element numbers for ease of understanding. Reference numbersmay have letter suffixes appended to indicate separate instances of acommon element while being referred to generically by the same numberwithout a suffix letter.

While the following description is directed to the administration ofmedical fluid to a patient by a medical professional using an IV setutilized the disclosed needleless connectors, it is to be understoodthat this description is only an example of usage and does not limit thescope of the claims. Various aspects of the disclosed needlelessconnectors may be used in any application where it is desirable to avoidblocking a fluid pathway.

FIG. 1 is a perspective view of an example needleless connector 10.Needleless connector 10 comprises a housing and a compressible valve100. The housing may be formed by a body portion 200 and a base portion300. However, in some embodiments, the housing may be formed from acombination of other pieces or parts similarly dimensioned to house thecompressible valve 100 therein. As illustrated in FIGS. 2A, 2B, and 2C,a central longitudinal axis 501 of needleless connector 10 may bedefined by orthogonal intersecting planes (plane 503 and plane 505)centrally aligned with respect to a first port 252 of the body portion200 and a second port 382 of the base portion 300. In operation, a fluidpathway may be established through needleless connector 10 from thefirst port 252 to the second port 382, for example.

A cross-sectional view illustrating a disposition of the compressiblevalve 100 within the housing of an assembled needleless connector 10along section line A-A of FIG. 2B is provided in FIG. 10. Variousaspects of compressible valve 100, body portion 200, and base portion300 will first be described in FIGS. 3A through 9C.

FIGS. 3A to 3C illustrate in isolation an example compressible valve100. Compressible valve 100 may comprise a head 110, a primary sealportion 120, and a lower portion 130. In certain embodiments, the head110 comprises a column section 118 having an axial center substantiallycorresponding to the central longitudinal axis 501 of the needlelessconnector 10. The central longitudinal axis 501 extends longitudinallythrough the head 110, primary seal portion 120, and lower portion 130 ofthe compressible valve 100. However, in some embodiments, the lowerportion of the compressible valve 100 may not have the same axial centeras the head or other portions of the compressible valve 100. Moreover,the axial centers of compressible valve sections substantially alignedwith the central longitudinal axis 501 of the needleless connector 10are noted with respect to the compressible valve 100 in a non-activatedstate (e.g., in isolation or within a connector but not displaced by amedical implement). The axial centers of compressible valve sectionswill change and pivot in relation to the central longitudinal axis 501upon the compressible valve being activated by a medical implement incertain examples.

The head 110 of the compressible valve 100 comprises a top section 112that includes a top surface 116. The top surface 116 may be oriented ata non-perpendicular plane angle with respect to the central longitudinalaxis 501 as illustrated in FIG. 3B. For example, the top surface 116 canbe dimensioned to have a diameter (D3-1) of approximately 0.171 inches.The head 110 comprises at least one notch 114 disposed along theexterior of the column section 118. In certain embodiments, the head 110may comprise a first notch 114 a and a second notch 114 b. The first andsecond notches 114 a, 114 b may be configured as arcuate-shaped recesseswithin the column section 118. However, it is to be appreciated that theimplementations of notches may comprise a variety of shapes and sizes,such as, but not limited to, notches having arcuate, triangular,polygonal, or various geometric cross-section shapes, for example.

In some embodiments, a head of a compressible valve may not include anotch, but rather has a discontinuity segment disposed on the columnsection that operates in a similar manner as a notch. For example, oneside or a portion of one side of the column section may be comprised ofa different material (or a same material with a different hardnessvalue) than the remainder of the column section. Additionally, a sideportion of the column section may be hollow (e.g., an internal notch).Thus, an effective change in the resiliency with respect to the movementof the head (similar to that of a removed or extracted volume of anotch) may result and be implemented in some embodiments.

As can be seen form the example embodiments illustrated in FIG. 3A to3C, the primary seal portion 120 includes a cross-section area greaterthan a cross-section area of the column section 118 of the head 110. Forexample, the primary seal portion 120 may comprise a frustoconicalsurface 122 for engaging with an internal sealing edge of a needlelessconnector housing. The frustoconical shape of the primary seal portion120 may be configured such that a first cross-sectional area of theprimary seal portion 120 proximal to the head 110 is smaller than asecond cross-sectional area of the primary seal portion 120 distally ofthe head 110 (i.e., where proximally refers to an orientation toward thetop surface 116 of the valve 100, and distally refers to an orientationtoward the base or bottom of the valve, opposite the top surface 116, asviewed in FIGS. 3A to 3C). In other words, the primary seal portion 120is narrower towards the head 110 and wider towards the lower portion 130in certain embodiments.

Lower portion 130 of the compressible valve 100 may comprise anelongated cylindrical wall 131 and a flange portion 135 for securing thecompressible valve within the housing. In certain embodiments, thecompressible valve 100 can be dimensioned to have a total length (D3-2)from the top surface 116 for the bottom of the flange portion 135 ofapproximately 0.800 to 0.780 inches. A length (D3-3) of the elongatedcylindrical wall 131 can be approximately 0.430 to 0.440 inches and adiameter (D3-4) of the flange portion 135 at its bottommost edge can beapproximately 0.350 inches in certain implementations.

FIG. 4A is a longitudinal cross-sectional view of the compressible valve100 along section line B-B of FIG. 3C. The top surface 116 may include anon-perpendicular plane. In certain embodiments, an angle (D4-1) can beapproximately 3° with respect to perpendicular plane to the centrallongitudinal axis 501. In some embodiments, the top section 112 of thehead 110 also includes a circumferential lip 115 or similar protrusiontherearound for slidably and sealably engaging with the port channel ofthe needleless connector housing. A circumferential side of the topsection 112 can be dimensioned to have an angle (D4-2) of approximately9° with respect to the central longitudinal axis 501. A first top edgeportion 414 a may be defined generally above the first notch 114 a and asecond top edge portion 414 b may be defined generally above the abovethe second notch 114 b (e.g., an arcuate portion of the circumferentialedge of the top surface 116 of the top section 112).

In certain embodiments, the first notch 114 a has a greater volume thanthe second notch 114 b in reference to the cylindrical shape of thecolumn section 118. In certain implementations, the first notch 114 amay be characterized as having an arcuate profile with a radialcomponent having a radius (D4-3) of approximately 0.111 inches extendingfrom a point that is a length (D4-3 and D4-4) of approximately 0.151inches from the axial center or central longitudinal axis 501 of thecompressible valve 100 and a length (D4-5) of approximately 0.550 incheslongitudinally from the bottom of the elongated cylindrical wall 131.

Similarly, the second notch 114 b may be characterized as having anarcuate profile with a radial component having a radius (D4-6) ofapproximately 0.125 inches extending from a point that is a length (D4-6and D4-7) of approximately 0.171 inches from the axial center or centrallongitudinal axis 501 of the compressible valve 100 and a length (D4-8)of approximately 0.547 inches longitudinally from the bottom of theelongated cylindrical wall 131. In this regard, the first and secondnotches 114 a, 114 b may be deemed as being formed with respect to anoffset axis parallel to the central longitudinal axis 501 that is alength (D4-9) of approximately 0.010 inches toward the second notch 114b (e.g., a revolve axis offset for the head 110 or upper portion of thecompressible valve 100).

Still referring to FIG. 4A, the lower portion 130 of the compressiblevalve 100 includes a closed end 136 proximal to the primary seal portion120 and an open end 138 distally of the primary seal portion 120. Aninterior wall 132 of the lower portion 130 may define, in part, aninterior air space 134 of the compressible valve 100. The lower portion130 may include various interior dimples, incisions, discontinuitysegments, or the like disposed along the interior wall 132 to facilitateproper compressing and collapsing functionality in accordance withvarious embodiments of the present disclosure.

For example, a first interior dimple 180 a and a second interior dimple180 b may be disposed on along the interior wall 132. The first interiordimple 180 a and the second interior dimple 180 b may be disposed onopposite sides of the interior wall 132 and at longitudinally differentpositions. Moreover, the size and shape of each interior dimple 180 a,180 b may be distinct. In certain embodiments, the first interior dimple180 a is larger than the second interior dimple 180 b. Moreover, thefirst notch 114 a may be longitudinally aligned with respect to thesecond internal dimple 180 b, and the second notch 114 b may belongitudinally aligned with respect to the first interior dimple 180 a.

The first interior dimple 180 a may be disposed proximal to the primaryseal portion 120, and the second interior dimple 180 b may be disposeddistally of the first interior dimple 180 a. Both the first and secondinterior dimples 180 a,180 b may be disposed along the interior wall 132of the elongated cylindrical wall 131 with respect to the centrallongitudinal axis 501. In this regard, a lateral center of the firstinterior dimple 180 a may be positioned at a length (D4-9) ofapproximately 0.275 inches longitudinally from the bottom of theelongated cylindrical wall 131 and a lateral center of the secondinterior dimple 180 b may be positioned at a length (D4-10) ofapproximately 0.115 inches longitudinally from the bottom of theelongated cylindrical wall 131.

The interior dimples 180 a, 180 b may be configured to have one or morelongitudinal arcuate components for defining elliptically and concavedshaped interior dimples. For example, first interior dimple 180 a maycomprise a major longitudinal arcuate component 181 a and a minorlongitudinal arcuate component 182 a defining an edge or border of thefirst interior dimple 180 a as shown in FIG. 4A. Similarly, secondinterior dimple 180 b may comprise a major longitudinal arcuatecomponent 181 b and a minor longitudinal arcuate component 182 bdefining an edge or border of the second interior dimple 180 b.

In certain embodiments, the thickness of the portion of the distance ofthe elongated cylindrical wall 131 may be thinnest at the lateral centerfor each of the corresponding interior dimples 180 a,180 b. For example,the thickness of the lateral center for each of the correspondinginterior dimples 180 a,180 b may be dimensioned to have length (D4-12)of approximately 0.013 inches. In other embodiments, each of theinterior dimples 180 a,180 b may be arranged to have differentthicknesses at its corresponding lateral center. For example, thelateral center of the first interior dimple 180 a may be formed suchthat it extends into the elongated cylindrical wall 131 a distance(D4-13) of approximately 0.110 inches from the axial center or centrallongitudinal axis 501.

Moreover, in some implementations, lateral radial components for whichthe interior dimples 180 a, 180 b are formed may be based from offsetaxes parallel to the central longitudinal axis 501. For example, thefirst interior dimple 180 a may be formed based on an offset axis thatis a length (D4-9) of approximately 0.010 inches toward the firstinterior dimple 180 a, and the second interior dimple 180 b may beformed based on an offset axis that is a length (D4-11) of approximately0.015 inches toward the second interior dimple 180 b.

FIG. 4B is a lateral cross-sectional view of the compressible valve 100along section line C-C of FIG. 3C at which the first internal dimple 180a is disposed. As discussed above, the first internal dimple 180 a maybe formed based on an offset axis that is a length (D4-9) ofapproximately 0.010 inches from the central longitudinal axis 501 thetoward a central region of the first interior dimple 180 a (e.g.,corresponding to a thinnest portion of the interior wall 132). A varyinglateral thickness of the portion of the interior wall 132 having thefirst internal dimple 180 a disposed thereon is illustrated in FIG. 4B.An exemplary concave shape of the first internal dimple 180 a can beunderstood with reference to the varying longitudinal thickness of theportion of the interior wall 132 having the first internal dimple 180 adisposed thereon, as illustrated in FIG. 4A.

Configuring elliptically and concave shaped interior dimples 180 a, 180b on the interior wall 132 as provided herein can aid in propercompressing (e.g., an initial bowing out of the interior dimple proximalto its lateral center) and subsequent collapsing, canting, and/orfolding of the lower portion 130 of the compressible valve 100 duringoperation of an assembled needleless connector.

FIG. 5A is an enlarged longitudinal cross-sectional view of the flangeportion 135 at detail region D of FIG. 4A. The flange portion mayinclude an inwardly facing lip 137 for interfacing with a valve mount ofa needleless connector housing, for example. The inwardly facing lip 137may extend along the entirety of the circumferential edge of the flangeportion 135. In certain embodiments, the inwardly facing lip 137 may bedimensioned to have an angle (D5-1) of approximately 9° with respect toa lateral or transverse plane of the flange portion 135 (i.e., withrespect to a plane perpendicular to central longitudinal axis 501).

FIG. 5B is an enlarged longitudinal cross-sectional view of the lowerportion 130 of the compressible valve 100 at detail region E of FIG. 4A.The elongated cylindrical wall 131 may have an exterior diameter (D5-2)of approximately 0.245 inches and an interior diameter (D5-3) ofapproximately 0.185 inches. Moreover, the flange portion 135 may have alength (D5-4) of approximately 0.110 inches.

Embodiments of the compressible valve 100 may comprise any of thevarious materials used for producing mechanical valves for needlelessconnectors and other medical implements. In some implementations, thehead 110 may be comprised of an elastomeric material, such as but notlimited to, a silicone compound. Moreover, the primary seal portion 120and lower portion 130 may comprise an elastomeric material. For example,in some implementations, the head 110 and primary seal portion 120 mayhave a durometer value of approximately 70+/−5 on a Shore A hardnessscale. In certain implementations, all or some of the compressible valve100 may be comprised of liquid silicone rubber of the Wacker ELASTOSIL®LR 3003 Series having a Shore A hardness durometer value of 70+/−5.

Additionally, in some embodiments, the elastomeric material of the head110 and/or primary seal portion 120 may have a higher durometer valuethan the elastomeric material of the lower portion 130. For example, thecollapsing functionality of the lower portion associated withfacilitating a fluid flow path in the needleless connector may benefitfrom a more pliable material for operation, whereas the head and primaryseal portion may require a more rigid construction for disengaging theprimary seal.

FIGS. 6A to 6C illustrate an example body portion 200 of a housing. Bodyportion 200 may comprise a first port 252 for interfacing with a medicalimplement and an opening 268 for connecting with a base portion of thehousing. Body portion 200 may comprise one or more fluid flow channels234 and one or more interior support columns 236. The lower section ofthe body portion 200 (e.g., a section proximal to the opening 268) mayhave an increased diameter and include one or more internal contact tabs266. When assembled in a needleless connector, the one or more internalcontact tabs 266 provide a radial force substantially orthogonal to thecentral longitudinal axis 501 onto a flange portion of a compressiblevalve that is arranged on a valve mount of the base portion.

FIG. 7A is a longitudinal cross-sectional view of the body portion 200along section line F-F of FIG. 6C. The first port 252 may include a topport surface 253 and a port channel 256. The first port 252 may includeengagement features for coupling to another device (e.g., fluid transferassembly). For example, engagement features may include cooperatingmechanical elements, such as internal or external surface threads,detents, bayonet-type locking elements, etc., as well as other surfaceconfigurations, such as a tapered Luer surface for frictionalengagement. In certain embodiments, the first port 252 can include afemale luer fitting with luer lock threading.

The body portion may include an internal cavity 242 and an internalsealing edge 254. The internal sealing edge 254 may be a circumferentialedge and configured for retaining a compressible valve within theinternal cavity 242 of an assembled needleless connector. In operation,the internal sealing edge 254 may be arranged to provide blocking offluid flow in conjunction with a primary seal portion of thecompressible valve.

In certain embodiments, fluid flow channels 234 may alternate withinterior support columns 236. This configuration is further illustrationin FIG. 7B, which provides a lateral cross-sectional view of the bodyportion 200 along section line G-G of FIG. 6C. In certain embodiments,fluid flow channels 234 may be smaller than the interior support columns236. For example, a fluid flow channel may be dimensioned to have across-sectional length (D7-1) of approximately 0.031 inches. In anassembled needleless connector, a top edge portion of a head of acompressible valve that is disposed above a notch in the head may bearranged such that each top edge portion 414 a, 414 b is aligned with aninterior support column 236 (e.g., where the top edge portion 414 aeffectively straddles two radially consecutive fluid flow channels 234and the top edge portion 414 b effectively straddles two radiallyconsecutive fluid flow channels 234 on opposite sides of the bodyportion). Thus, in smaller dimensioned needleless connectors, blockageof a fluid flow path and/or damage to the top edge and notch of the headand/or a portion of the frustoconical surface/primary seal disposedproximal to the notch from continued contact with a longitudinallytransition edge formed between an adjacent flow channel 234 and interiorsupport column 236 can be avoided by such an arrangement.

Additionally, fluid flow channels 234 may further extend into the lowerportion of the body portion 200 between adjacent internal contact tabs266 (FIG. 7A). In this regard, a fluid path may be extended to a baseportion of the housing coupled to the body portion 200 and further to asecond port.

FIGS. 8A to 8D illustrate in isolation an example base portion 300 of ahousing. The base portion 300 may comprise a second port 382 forinterfacing with a medical implement and a valve mount 355. The valvemount 355 may comprise a rim 350 that defines a recess 340 with one ormore air passages 372. The base portion 300 may comprise one or morefluid passages 374 for completing a fluid flow path from the internalcavity and fluid flow channels of the body portion to the second port382 of the base portion 300. The rim 350 of the valve mount 355 mayinclude an upper partial transverse wall 353 (e.g., partially extendingin a plane transverse to the central longitudinal axis 501) and a lowerpartial transverse wall 357.

The base portion 300 is dimensioned to be coupled to and fused with thebody portion 200 to create a housing of a needleless connector. Forexample, the base portion 300 at its thickest section may be dimensionedto have a diameter (D8-1) of approximately 0.455 inches. Additionally,the base portion 300 may be dimensioned to have a length (D8-2) ofapproximately 0.505 inches.

FIG. 9A is a longitudinal cross-sectional view of the base portion 300along section line H-H of FIG. 8C. The second port 382 may includeengagement features for coupling to another device or to interconnecttubing. For example, the second port 382 may comprise a male luer-taperfitting and luer lock threading 384 for medical device implementinterconnection. However, engagement features of the second port 382 mayinclude other cooperating mechanical elements. The one or more fluidpassages 374 are configured to be fluidly coupled to the internal cavity242 via the one or more fluid flow channels 234 (e.g., when the housingis assembled) and to complete a fluid flow path to the second port 382.

FIG. 9B is a longitudinal cross-sectional view of the base portion 300along section line J-J of FIG. 8D. Air passage channels 372 mayfacilitate an air flow path from an internal air space of thecompressible valve 100 (e.g., when the compressible valve 100 is coupledto the valve mount 355 and secured within the housing) to a connecteddevice (e.g., via luer lock threading 384) or to ambient environment.FIG. 9C is a lateral overhead view of the base portion 300 along sectionline K-K of FIG. 8D. The base portion 300 may include one or moresupport members 380 that extend from the rim 350 laterally into therecess 340. When assembled, a top surface of the rim 350 (e.g., theupper partial transverse wall 353 and the one or more support members380) may contact with the flange portion 135. The recess 340 includes abottom surface 360 that is distally separated from the top surface ofthe rim 250. The bottom surface in cooperation with other aspects of thebase portion 340 can also provide a barrier between the fluid pathways(e.g., one or more fluid passages 374) and the air flow paths (e.g., airpassage channels 372).

FIG. 10 provides a longitudinal cross-sectional view of needlelessconnector 10 showing the compressible valve 100 in the housing formed bythe body portion 200 and the base portion 300. The cross-sectional viewof FIG. 10 is of the needleless connector 10 along section line A-A ofFIG. 1C. The assembled needleless connection 10 as illustrated in FIG.10 is in a sealed configuration such that any fluid from aninterconnected fluid path coupled to the second port 382 is sealed fromthe first port 252.

Needleless connector 10 may be assembled such that the flange portion135 of the compressible valve 100 (FIGS. 3A to 5B) is coupled or snappedonto the valve mount 355 of the base portion 300. For example, theflange portion 135 may include an inwardly facing lip 137 and partialtransverse upper wall abutting the elongated cylindrical wall 131 suchthat the flange portion 135 can securely engage with the valve mount355. The rim 350 of the valve mount 355 may include an upper partialtransverse wall 353 and a lower partial transverse wall 357 tofacilitate such a secure engagement with the flange portion 135 andcompressible valve 100.

The opening 268 of the body portion 200 (FIGS. 6A to 7B) may be arrangedon top of the compressible valve 100 coupled to the base portion 300such that the head 110 of the compressible valve 100 is aligned anddisposed within the port channel 256 of the first port 252. Uponassembly, the top surface 116′ of the head 110 of the compressible valve100 has a resulting plane that is substantially perpendicular to thecentral longitudinal axis 501 or axial center of the column section 118of the head 110 when the head 110 is engaged within the port channel 256of the housing. Additionally, the one or more internal contact tabs 266disposed on the lower section of the body portion 200 surround and applypressure to a sidewall of the flange portion 135 to secure or anchor thecompressible valve 100 in the housing. In operation, the compressiblevalve 100 of the needleless connector can compress and collapse when anaxial force is applied to the top surface 116′ of the compressible valve100 and expand and realign when the axial force is removed.

Accordingly, the one or more internal contact tabs 266 provide a radialforce 525 substantially orthogonal to the central longitudinal axis 501onto the sidewall of the flange portion 135 and the rim 350 of the baseportion 300. In this regard, when an axial force is applied to the topsurface 116′ of the head 110 of the compressible valve 100, the effectof any resulting axial force through the compressible valve 100 onto thebase portion 300 is reduced if not eliminated. Such a resulting axialforce applied onto the base portion 300 can work against or inderogation to the fused connection 550 of the base portion 300 and thebody portion 200, and over time may cause the fused connection 550 tobecome breached and/or separated.

FIG. 11A provides a longitudinal cross-sectional view of needlelessconnector 10 showing the compressible valve 100 upon initial entry of amedical implement 50 into the first port 252. The cross-sectional viewof FIG. 11A is of the needleless connector 10 along section line A-A ofFIG. 1C as would be modified by the described valve operation.

As medical implement 50 (e.g., an syringe) is initially inserted intothe first port 252 of the needleless connector 10, an initial axialforce 511 is exerted onto the compressible valve 100 such that a centralportion 185 a of the elongated cylindrical wall 131 proximal to thefirst interior dimple 180 a may slightly bow out toward the inner wallof the body portion 200 (e.g., the fluid flow channels 234 and interiorsupport columns 236). Additionally, the frustoconical surface 122 of theprimary seal portion 120 may separate from the internal sealing edge254.

FIG. 11B provides a longitudinal cross-sectional view of needlelessconnector 10 showing the compressible valve 100 after further entry ofthe medical implement 50 into the first port 252. The cross-sectionalview of FIG. 11A is of the needleless connector 10 along section lineA-A of FIG. 1C as would be modified by the described valve operation.

Upon additional axial force 511, the medical implement 50 descendsfurther into the first port 252, further compressing, collapsing,canting, and/or folding may occur with respect to certain sections ofthe compressible valve 100. For example, as illustrated in FIG. 11B, abottom portion 186 a of the elongated cylindrical wall 131 proximal tothe first interior dimple 180 a may fold inwardly and underneath a topportion 184 a. Similarly, a bottom portion 186 b of the elongatedcylindrical wall 131 proximal to the second interior dimple 180 b mayfold inwardly and underneath a top portion 184 b.

Additionally, the first notch 114 a may fold or collapse and the secondnotch 114 b may open or expand such that the first top edge portion 414a may tilt downwardly. In this regard, a fluid path from the medicalimplement 50 in the first port 252 may be established through theinterior of the needleless connector 10 to the second port 382. Forexample, a fluid path may be established between the first port 252 andthe second port 382 via the internal cavity 242 and the fluid flowchannels 234 (FIGS. 6B, 7A, and 7B), to the base portion 300 and throughfluid passages 374, and into the second port 382 (FIGS. 8A, 8C, and 9A).

Moreover, as discussed above, the second top edge portion 414 b, thesecond notch 114 b, and/or a portion of the frustoconical surface 122disposed proximal to the second notch 114 b may be positioned such thatthey predominantly contact an interior support column 236 of the bodyportion 200 (FIGS. 7A and 7B) while in the compressed configuration.

When the medical implement 50 is removed from the first port 252, thecompressible valve 100 may return to its position within the housing inthe sealed configuration as illustrated in FIG. 10.

The present disclosure is provided to enable any person skilled in theart to practice the various aspects described herein. The disclosureprovides various examples of the subject technology, and the subjecttechnology is not limited to these examples. Various modifications tothese aspects will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

In one aspect, the term “coupled” or the like may refer to beingdirectly coupled. In another aspect, the term “coupled” or the like mayrefer to being indirectly coupled.

Terms such as “top,” “bottom,” “front,” “rear” and the like if used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Various items may be arranged differently (e.g., arranged in a differentorder, or partitioned in a different way) all without departing from thescope of the subject technology.

It is understood that the specific order or hierarchy of steps,operations or processes disclosed is an illustration of exemplaryapproaches. Based upon design preferences, it is understood that thespecific order or hierarchy of steps, operations or processes may berearranged. Some of the steps, operations or processes may be performedsimultaneously. Some or all of the steps, operations, or processes maybe performed automatically, without the intervention of a user. Theaccompanying method claims, if any, present elements of the varioussteps, operations or processes in a sample order, and are not meant tobe limited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112, sixth paragraph, unless theelement is expressly recited using the phrase “means for” or, in thecase of a method claim, the element is recited using the phrase “stepfor.” Furthermore, to the extent that the term “include,” “have,” or thelike is used, such term is intended to be inclusive in a manner similarto the term “comprise” as “comprise” is interpreted when employed as atransitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but is to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should theybe interpreted in such a way.

What is claimed is:
 1. A needleless connector comprising: a housingdefining an internal cavity and a central longitudinal axis, the housingcomprising a body section and a base section, the body sectioncomprising a first port, and the base section comprising a valve mountat a top of the base section and a second port at a bottom of the basesection, the valve mount comprising an upper wall, a lower wall, and avalve mount rim, wherein the upper and lower walls extend from the valvemount rim toward the central longitudinal axis; and a compressible valvecomprising a valve wall and a flange protruding radially outward from anouter surface of the valve wall, the flange comprising an outer surfaceand an inner surface forming a channel, wherein, when the compressiblevalve is coupled with the valve mount, the valve mount rim extends intothe channel.
 2. The needleless connector of claim 1, wherein the channelextends into the inner surface, toward the outer surface of the flange.3. The needleless connector of claim 1, wherein the body sectioncomprises an inner contact tab extending into the internal cavity, and,when the compressible valve is coupled with the valve mount and the bodysection, at least a portion of the flange is positioned between thevalve mount and the contact tab.
 4. The needleless connector of claim 1,wherein the valve wall comprises a first dimple and a second dimpleformed in an internal surface.
 5. The needleless connector of claim 1,wherein base section comprises a recess between the valve mount and thesecond port.
 6. The needleless connector of claim 5, wherein supportmembers extend laterally inward from the valve mount into the recess. 7.The needleless connector of claim 5, wherein the body section comprisesan inner support column.
 8. The needleless connector of claim 5, whereinthe valve mount rim extends from the upper wall toward the bottom of thebase section.
 9. A needleless connector comprising: a housing definingan internal cavity and a central longitudinal axis, the housingcomprising a body section and a base section, the body sectioncomprising a first port, and the base section comprising a valve mountat a top of the base section and a second port at a bottom of the basesection, the valve mount comprising an upper wall, a lower wall, and avalve mount rim; and a compressible valve comprising a valve wall and aflange protruding radially outward from an outer surface of the valvewall, the flange comprising an upper lip, a lower lip, and a flange rim,wherein, when the compressible valve is coupled with the valve mount,the lower lip extends along the lower wall toward the centrallongitudinal axis.
 10. The needleless connector of claim 9, wherein thelower lip is spaced apart from the upper lip.
 11. The needlelessconnector of claim 9, wherein a channel is formed between an innersurface of the upper lip and an inner surface of the lower lip.
 12. Theneedleless connector of claim 9, wherein an outer surface of the flangerim tapers from the lower lip toward the upper lip.
 13. The needlelessconnector of claim 9, wherein a height of the lower lip taper toward thecentral longitudinal axis.
 14. The needleless connector of claim 9,wherein the body section comprises an inner contact tab extending intothe internal cavity, and, when the compressible valve is coupled withthe valve mount and the body section, at least a portion of the flangeis positioned between the valve mount and the contact tab.
 15. Theneedleless connector of claim 9, wherein the valve wall comprises afirst dimple and a second dimple formed in an internal surface.
 16. Theneedleless connector of claim 9, wherein base section comprises a recessbetween the valve mount and the second port.
 17. The needlelessconnector of claim 16, wherein support members extend laterally inwardfrom the valve mount into the recess.
 18. The needleless connector ofclaim 17, wherein the support members extend between the upper wall anda bottom surface of the recess.
 19. The needleless connector of claim 9,wherein the body section comprises an inner support column.
 20. Theneedleless connector of claim 9, wherein the valve mount rim extendsfrom the upper wall toward the bottom of the base section.